Methods and apparatus for implanting electronic implants within the body

ABSTRACT

Apparatus and methods for implanting electronic implants within the body are described herein. Such electronic implants can include, for example, elongated stimulating devices, sensors and/or electronic leads. In some embodiments, an apparatus includes a first member and a second member operatively coupled to the first member. The first member has a proximal end portion and a distal end portion. The distal end portion of the first member includes a target probe. The second member has a proximal end portion and a distal end portion. The distal end portion of the second member is configured to be selectively coupled to an electronic implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. patent application Nos. 11/972,396and 11/972,402 (U.S. Patent Publication Nos. 2009/0182402 and2009/0182403, respectively), each entitled “Methods and Apparatus forImplanting Electronic Implants within the Body,” filed on Jan. 10, 2008,each of which is incorporated herein by reference in their entirety.

BACKGROUND

The invention relates generally to medical devices and procedures, andmore particularly to apparatus and methods for implanting electronicimplants within the body.

Electronic implants, such as, for example, electrical stimulation leadsand/or electrical sensing leads, are used in various medical procedures.For example, some known electronic implants can be implanted within apatient's body to stimulate a response from a bodily organ or tissue,such as, for example, the heart, a muscle group or the like. Some knownelectronic implants can be implanted within a patient's body to sense aresponse from a bodily organ or tissue. Accordingly, known electronicimplants can be inserted into the patient's body in a known locationand/or orientation (e.g., such that a portion of the implant is inelectrical contact with a nerve).

Known methods for implanting electronic implants within a patient's bodycan include first locating a desired target tissue using an targetingprobe and then inserting the electronic implant adjacent the targettissue. Such known methods can include inserting the electronic implantvia a passageway having a shallow angle relative to the skin surface(i.e., a passageway that is offset from the skin surface by a smallangle). This method of insertion can be used, for example, to ensurethat there is sufficient bodily tissue depth to maintain the position ofthe electronic implant when the target tissue is located at a shallowdepth below the skin surface. Such known methods, however, often fail toaccurately position the electronic implant adjacent the target tissue.

Thus, a need exists for improved methods and apparatus for implantingelectronic implants within a patient's body.

SUMMARY

Apparatus and methods for implanting electronic implants within the bodyare described herein. Such electronic implants can include, for example,elongated stimulating devices, sensors and/or electronic leads. In someembodiments, an apparatus includes a first member and a second memberoperatively coupled to the first member. The first member has a proximalend portion and a distal end portion. The distal end portion of thefirst member includes a target probe. The second member has a proximalend portion and a distal end portion. The distal end portion of thesecond member is configured to be selectively coupled to an electronicimplant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration, and a third configuration, respectively.

FIGS. 4-7 are front views of a medical device according to an embodimentof the invention in a first configuration, a second configuration, athird configuration, and a fourth configuration, respectively.

FIGS. 8-10 are partial cross-sectional front views of a medical deviceaccording to an embodiment of the invention in a first configuration, asecond configuration, and a third configuration, respectively.

FIGS. 11-13 are front views of a medical device according to anembodiment of the invention in a first configuration, a secondconfiguration, and a third configuration, respectively.

FIGS. 14 and 15 are partial cross-sectional front views of a medicaldevice according to an embodiment of the invention in a firstconfiguration and a second configuration, respectively.

FIGS. 16-18 are cross-sectional front views of a medical deviceaccording to an embodiment of the invention in a first configuration, asecond configuration, and a third configuration, respectively.

FIG. 19 is a cross-sectional front view of a medical device according toan embodiment of the invention.

FIGS. 20 and 21 are schematic illustrations of a medical deviceaccording to an embodiment of the invention in a first configuration anda second configuration, respectively.

FIG. 22 is a schematic illustration of a portion of a medical deviceaccording to an embodiment of the invention.

FIGS. 23 and 24 are front views of a medical device according to anembodiment of the invention in a first configuration and a secondconfiguration, respectively.

FIGS. 25-28 are flow charts of methods of inserting an implant into abody according to embodiments of the invention.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a first member and a secondmember operatively coupled to the first member. The first member has aproximal end portion and a distal end portion. The distal end portion ofthe first member includes a target probe. The second member has aproximal end portion and a distal end portion. The distal end portion ofthe second member is configured to be selectively coupled to anelectronic implant, such as, for example, a microstimulator, an elongateimplant, an electronic lead, an electrode, and/or a sensor.

In some embodiments, an apparatus includes a first member and a secondmember movably coupled to the first member. The first member has atarget portion configured to define a first passageway within a body.The first passageway extends from a first insertion location to a targetlocation within the body. The second member is configured to define asecond passageway within the body when the target portion of the firstmember is within the body. The second passageway, which is distinct fromthe first passageway, extends from a second insertion location to thetarget location.

In some embodiments, an apparatus includes a first member and a secondmember movably coupled to the first member. The first member has atarget portion configured to define a first passageway within a body.The first passageway extends from a first insertion location to a targetlocation within the body. The second member has a distal end portion anda proximal end portion. The distal end portion is configured to define asecond passageway within the body when the target portion of the firstmember is within the body. The second passageway, which is distinct fromthe first passageway, extends from a second insertion location to thetarget location. The distal end portion is further configured to beselectively coupled to an electronic implant such that the second membercan deliver the electronic implant from a location outside of the bodyto the target location within the body via the second passageway. Theproximal end portion of the second member includes an actuatorconfigured to selectively decouple the distal end portion of the secondmember from the electronic implant.

In some embodiments, an apparatus includes an implant delivery deviceconfigured to deliver an electronic implant into a body. The implantdelivery device includes a target portion and an insertion portion, andhas a first configuration and a second configuration. The target portionof the implant delivery device is configured to be disposed within thebody and convey an electrical signal between a target location withinthe body and an electrical device disposed outside of the body when theimplant delivery device is in the first configuration. A distal endportion of the insertion portion is configured to be disposed outside ofthe body when the implant delivery device is in the first configuration.The distal end portion of the insertion portion is configured to bedisposed within the body at the target location when the implantdelivery device is in the second configuration. In some embodiments, forexample, the distal end portion of the insertion portion is configuredto be selectively coupled to the electronic implant.

In some embodiments, an apparatus includes an elongate member and atarget device. The elongate member is configured to be selectivelycoupled to an electronic implant, such as, for example, amicrostimulator, an elongate implant, an electronic lead, an electrode,and/or a sensor. The target device includes a first portion and a secondportion. The first portion of the target device defines a lumenconfigured to receive at least a portion of a target probe, which can,for example, electrically stimulate at least one of a nerve or a musclewhen the target probe is within the body. The second portion of thetarget device defines a lumen configured to receive at least a portionof the elongate member. The second portion of the target device isconfigured to move relative to the first portion of the target devicebetween a first position and a second position. A portion of a centerline of the lumen of the first portion and a portion of a center line ofthe lumen of the second portion define a first angle when the secondportion of the target device is in the first position. The portion ofthe center line of the lumen of the first portion and the portion of thecenter line of the lumen of the second portion define a second anglewhen the second portion of the target device is in the second position.The second angle is different than the first angle.

In some embodiments, a method includes inserting a target probe along afirst path within a body such that a portion of the target probe isdisposed adjacent a target location within the body. The target locationcan be, for example, a portion of a nerve, a muscle or the like. Anelectronic implant is inserted along a second path within the body suchthat a portion of the electronic implant is disposed adjacent the targetlocation within the body. The second path is different from the firstpath. The electronic implant is inserted when the target probe isdisposed adjacent the target location within the body.

In some embodiments, a method includes inserting a target probe of afirst member of an implant delivery device into a body via a firstincision such that a portion of the target probe is disposed within thebody adjacent a target location. A second member of the implant deliverydevice is moved relative to the first member such that a distal endportion of the second member is moved from a region outside of the bodyto the target location within the body via a second incision. The secondincision is physically distinct from the first incision. The distal endportion of the second member is selectively coupled to an electronicimplant. In some embodiments, the method further includes decoupling theelectronic implant from the distal end portion of the second memberafter the second member of the implant delivery device is moved.

In some embodiments, a method includes engaging a target device with anouter surface of a body. The target device includes a first portion anda second portion. The first portion defines a lumen and the secondportion defines a lumen. A distal end portion of a target probe isinserted into the body via the lumen of the first portion. The secondportion of the target device is moved relative to the first portion ofthe target device. In some embodiments, for example, the second portionof the target device can be rotated within an opening defined by thefirst portion of the target device. A distal end portion of an implantdelivery member is inserted into the body via the lumen of the secondportion. In some embodiments, for example, the distal end portion of theimplant delivery member is selectively coupled to an electronic implantand the method can further include decoupling the distal end portion ofthe implant delivery member and the electronic implant.

In some embodiments, an apparatus includes an implant delivery deviceconfigured to deliver an implant into a body. The implant deliverydevice includes a target member, an insertion member and an electroniccircuit system. The target member has a distal end portion configured tobe disposed within the body adjacent a target location, which can be,for example, a nerve, a muscle or the like. The insertion member ismovably coupled to the target member. A distal end portion of theinsertion member is configured to be disposed within the body andselectively coupled to the implant. The electronic circuit system isconfigured to produce an electronic signal in proportion to a distancebetween the distal end portion of the target member and the distal endportion of the insertion member when the target member and the insertionmember are disposed within the body. In some embodiments, the electronicsignal is associated with an impedance between the distal end portion ofthe target member and the distal end portion of the insertion member. Inother embodiments, the electronic signal is associated with any othersuitable electronic characteristic, such as for example, a resistancebetween the distal end portion of the target member and the distal endportion of the insertion member, a capacitance between the distal endportion of the target member and the distal end portion of the insertionmember, and/or an inductance between the distal end portion of thetarget member and the distal end portion of the insertion member.

In some embodiments, an apparatus includes an implant delivery deviceconfigured to deliver an implant into a body. The implant deliverydevice includes a target member, an insertion member and positionindicator. The target member has a distal end portion configured to bedisposed within the body adjacent a target location. The insertionmember is movably coupled to the target member. A distal end portion ofthe insertion member is configured to be disposed within the body andselectively coupled to the implant. The position indicator is configuredto indicate a position of the distal end portion of the target memberrelative to the distal end portion of the insertion member when thetarget member and the insertion member are disposed within the body. Insome embodiments, for example, the position indicator includes a firstportion and a second portion. The first portion is coupled to the targetmember and includes a plurality of graduated markings. The secondportion is coupled to the insertion member and includes a pointerconfigured to move relative to the graduated markings of the firstmember.

In some embodiments, a method includes inserting a distal end portion ofa target probe into a body. An implant is inserted into the body. Adistance between the distal end portion of the target probe and theimplant is measured after the distal end portion of the target probe isinserted and the implant is inserted. The implant is moved within thebody in response to the measuring.

In some embodiments, a method includes inserting a distal end portion ofa target probe into a body using an implant delivery device via a firstincision. An implant is inserted into the body using the implantdelivery device via a second incision. The second incision is physicallydistinct from the first incision. A distance between the distal endportion of the target probe and the implant is measured after the distalend portion of the target probe is inserted and the implant is inserted.The implant is moved within the body in response to the measuring.

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, an operator(e.g., surgeon, physician, nurse, technician, etc.) who would use amedical device or a therapeutic device during a procedure. For example,the end of a medical device first to contact and/or be inserted into thepatient's body would be the distal end, while the opposite end of themedical device (e.g., the end of the medical device being operated bythe operator or the end of the medical device last to be inserted intothe patient's body) would be the proximal end of the medical device.

The term “parallel” is used herein to describe a relationship betweentwo objects (e.g., a first tubular member, a second tubular member, alumen or the like) and/or the geometric constructions defined by twoobjects (e.g., a longitudinal axis) in which the two objects and/or thetwo geometric constructions are substantially non-intersecting if theyextend substantially to infinity. For example, as used herein in thecontext of geometrical constructions, when a planar surface (i.e., atwo-dimensional surface) is said to be parallel to a line (e.g., alongitudinal axis), every point along the line is spaced apart from thenearest portion of the planar surface by a substantially equal distance.Similarly, as used herein in the context of two objects, a first object(e.g., a first tubular member) is said to be parallel to a second object(e.g., a second tubular member) when a longitudinal axis of the firstobject and a longitudinal axis of the second object do not intersect ifthey were extended to infinity. Two objects and/or geometricconstructions are described herein as being “parallel” or “substantiallyparallel” to each other when they are nominally parallel to each other,such as for example, when they are parallel to each other within atolerance. Such tolerances can include, for example, manufacturingtolerances, measurement tolerances or the like.

The term “normal” is used herein to describe a relationship between twoobjects (e.g., a first tubular member, a second tubular member, a lumenor the like) and/or the geometric constructions defined by two objects(e.g., a longitudinal axis, a planar surface or the like) in which thetwo objects and/or the two geometric constructions intersect at an angleof approximately 90 degrees within at least one plane. For example, asused herein in the context of two objects, a first object is said to benormal to a second object when a longitudinal axis of the first objectand a longitudinal axis of the second object intersect at an angle ofapproximately 90 degrees within a plane.

The terms “member” and “device” as used herein can refer to either asingle item or multiple items that cooperatively perform one or morefunctions. For example, as used herein, a member can include a singlecomponent or can be constructed from multiple components coupledtogether. More particularly, when a member includes a single component,the single component can be, but is not necessarily, monolithicallyconstructed from a single material. When a member is constructed frommultiple components, in some embodiments, the various components canmove relative to each other. Conversely, in other embodiments, thevarious components from which the member is constructed can be in afixed position relative to each other whether or not monolithicallyformed.

The term “electronic implant” as used herein can refer to either animplant including active electronic circuitry or an implant including apassive portion of an electronic circuit system. For example, as usedherein, an electronic implant can include active devices, such asmicrostimulators, amplifiers, power supplies, sensors or he like. Anelectronic implant can also include passive devices, such as passiveleads, wires, or the like.

FIGS. 1-3 are schematic illustrations of a medical device 100 accordingto an embodiment of the invention in a first configuration, a secondconfiguration, and a third configuration, respectively. The medicaldevice 100 includes a target member 110 and an insertion member 140. Thetarget member 110 has a proximal end portion 112 and a distal endportion 113. The distal end portion 113 includes a target probe 114configured to locate a target tissue T within the body B. For example,in some embodiments, the target probe 114 can be an electronicstimulating probe having an exposed electrode configured to stimulate amuscle, a nerve or the like and/or receive an electronic signal from amuscle, nerve or the like to locate the target tissue T.

The insertion member 140 has a proximal end portion 142 and a distal endportion 143. The distal end portion 143 of the insertion member 140 isselectively coupled to an implant 102. The selective coupling of thedistal end portion 143 of the insertion member 140 and the implant 102can be accomplished by any suitable means, such as, for example, amechanical coupling (e.g., an interference fit, detents, a threadedcoupling, or the like), an electronic coupling (e.g., a magneticcoupling), a chemical bond, a hydraulic coupling and/or a pneumaticcoupling (e.g., a vacuum coupling). The implant 102 can be an electronicimplant, such as, for example, a microstimulator, an elongate implant,an electronic lead, an electrode, a power supply, an amplifier and/or asensor. Although the implant 102 is shown as being coupled to thedistal-most portion of the insertion member 140, in other embodiments,the implant 102 can be selectively coupled in any suitable locationalong the distal end portion 143 of the insertion member 140.

The proximal end portion 142 of the insertion member 140 is rotatablycoupled to the proximal end portion 112 of the target member 110 at acoupling joint 165. The coupling joint 165 can include, for example apin, a ball and socket joint, a hinge or the like. In this manner, theinsertion member 140 can rotate relative to the target member 110 aboutthe coupling joint 165. Said another way, the proximal end portion 142of the insertion member 140 can rotate about an axis substantiallynormal to a longitudinal axis of the target member 110. Moreover, insome embodiments, such as, for example, those embodiments in which thecoupling joint 165 is a ball and socket joint, the proximal end portion142 of the insertion member 140 can rotate about the longitudinal axisof the target member 110. In this manner, as described in more detailherein, the proximal end portion 142 of the insertion member 140 can berotated to allow for multiple locations of the insertion I₂.

As shown in FIG. 1, the medical device 100 can be placed in the firstconfiguration by inserting the distal end portion 113 of the targetmember 110 into the body B through a first incision I₁ in the skin S.The distal end portion 113 is inserted via a first passageway P₁ suchthat the distal tip 116 of the target probe 114 is adjacent the targettissue T. In some embodiments, the distal tip 116 of the target probe114 is configured to pierce, dilate and/or displace bodily tissue todefine the first passageway P₁ to locate the target tissue T. Saidanother way, when the medical device 100 is in the first configuration,the distal tip 116 of the target probe 114 is positioned at apredetermined location (e.g., proximate a particular anatomicalstructure, at a desired depth or the like) within the patient's body B.Although the distal tip 116 of the target probe 114 is shown as beingadjacent the target tissue T, in other embodiments, the target member110 can be inserted such that the distal tip 116 of the target probe 114is within the body B at a depth greater than a depth of the targettissue T. Said another way, in some embodiments, the target member 110can be inserted such that the a portion of the target probe 114 otherthan the distal tip 116 is adjacent the target tissue T.

When the medical device 100 is in the first configuration, the distalend portion 143 of the insertion member 140 is coupled to the implant102. Additionally, the insertion member 140 is in a first positionrelative to the target member 110 such that the distal end portion 143of the insertion member 140 is disposed outside of the body B. Similarlystated, when the medical device 100 is in the first configuration, theinsertion member 140 is angularly offset from the target member 110 by afirst angle α₁. In some embodiments, the medical device 100 can bemaintained in its first configuration by a ratchet mechanism, a detent,a biasing member, a locking mechanism or the like.

When the distal tip 116 of the target probe 114 is adjacent the targettissue T, the insertion member 140 can be rotated relative to the targetmember 110 as shown by the arrow AA in FIG. 2. In this manner, themedical device 100 can be moved between the first configuration and thesecond configuration. When the medical device 100 is in the secondconfiguration, the insertion member 140 is in a second position relativeto the target member 110 such that the distal end portion 143 of theinsertion member 140 is disposed within the body B. Similarly stated,when the medical device 100 is in the second configuration, theinsertion member 140 is angularly offset from the target member 110 by asecond angle α₂. In some embodiments, the medical device 100 can bemaintained in its second configuration by a ratchet mechanism, a detent,a biasing member, a locking mechanism or the like. Similarly, in someembodiments, the movement of the insertion member 140 relative to thetarget member 110 can be limited by a mechanical stop, a detent, alocking mechanism, a ratchet mechanism or the like. In this manner, themovement of the insertion member 140 relative to the target member 110can be controlled to prevent the distal end portion 143 of the insertionmember 140 from overshooting (i.e., moving past) the target tissue Tand/or the distal tip 116 of the target probe 114.

When the medical device 100 is moved between the first configuration(FIG. 1) and the second configuration (FIG. 2), the distal end portion143 of the insertion member 140 is inserted into the body B through asecond incision I₂ in the skin S. The distal end portion 143 of theinsertion member 140 is moved within the body B via a second passagewayP₂ such that the distal end portion 143 of the insertion member 140 isadjacent the target tissue T and/or the distal tip 116 of the targetprobe 114. Said another way, when the medical device 100 is movedbetween the first configuration and the second configuration, theinsertion member 140 is moved relative to the target member 110 betweenthe first position and the second position such that the distal endportion 143 of the insertion member 140 is moved from a region outsideof the body to a region within the body B. Moreover, when the medicaldevice 100 is moved between the first configuration and the secondconfiguration, the distal end portion 143 of the insertion member 140remains coupled to the implant 102. Accordingly, when the medical device100 is moved between the first configuration and the secondconfiguration, the implant 102 is moved from a region outside of thebody to a region within the body B.

In some embodiments, the distal end portion 143 of the insertion member140 is configured to pierce, dilate and/or displace bodily tissue todefine the second passageway P₂. For example, in some embodiments, thedistal end portion 143 of the insertion member 140 can include a taperedtip (not shown in FIGS. 1-3). In other embodiments, a distal portion ofthe implant 102 can extend from the distal end portion 143 of theinsertion member and be configured to pierce, dilate and/or displacebodily tissue to define the second passageway P₂.

As shown in FIG. 2, the first passageway P₁ extends along asubstantially linear path from the first incision I₁ to a region withinthe body B adjacent the target tissue T. Although the first passagewayP₁ is shown as being substantially linear, in other embodiments, thefirst passageway P₁ can be of any suitable shape. Similarly, the secondpassageway P₂ extends along a curved path from the second incision I₂ toa region within the body B adjacent the target tissue T. Although thesecond passageway P₂ is shown as being curved, in other embodiments, thesecond passageway P₂ can be of any suitable shape. Moreover, the secondincision I₂ is physically distinct from the first incision I₁. Saidanother way, the first incision I₁ and the second incision I₂ do notshare a common boundary. In this manner, the size of the first incisionI₁ and/or the second incision I₂ can be minimized to reduce patienttrauma.

Similarly, the first passageway P₁ is distinct from the secondpassageway P₂. Said another way, at least a portion of the firstpassageway P₁ and at least a portion of the second passageway P₂ do notshare a common border. Moreover, as shown in FIG. 2, a center line CL₁of the first passageway P₁ and a center line CL₂ of the secondpassageway P₂ are angularly offset. In some embodiments, for example, aportion of the center line CL₂ of the second passageway P₂ can besubstantially normal to a portion of the center line CL₁ of the firstpassageway P₁ and/or the targeting probe 114.

When the distal end portion 143 of the insertion member 140 and/or theimplant 102 is adjacent the target tissue T, the distal end portion 143of the insertion member 140 can be decoupled from the implant 102. Theinsertion member 140 can then be rotated relative to the target member110 as shown by the arrow BB in FIG. 3, thereby placing the medicaldevice 100 in the third configuration. When the medical device 100 ismoved between the second configuration (FIG. 2) and the thirdconfiguration (FIG. 3), the distal end portion 143 of the insertionmember 140 is removed from within the body B via the second passagewayP2 and the second incision I₂. Said another way, when the medical device100 is moved between the second configuration and the thirdconfiguration, the insertion member 140 is moved relative to the targetmember 110 between the second position and a third position such thatthe distal end portion 143 of the insertion member 140 is moved from aregion within the body B to a region outside of the body, while theimplant 102 remains within the body B adjacent the target tissue Tand/or the distal tip 116 of the target probe 114.

FIGS. 4-7 are front views of a medical device 200 according to anembodiment of the invention in a first configuration, a secondconfiguration, a third configuration, and a fourth configuration,respectively. The medical device 200 includes a target member 210, aninsertion member 240, and a coupling member 264. The target member 210has a proximal end portion 212 and a distal end portion 213. The distalend portion 213 includes an anchor portion 228 having a contact surface220 configured to be disposed against the skin S of a body B. In thismanner, the position of the target member 210 relative to the body B canbe maintained throughout the operation of the medical device 200. Insome embodiments, for example, the anchor portion 228 and/or the contactsurface 220 can be configured to limit movement of the target member 210relative to the body B when the contact surface 220 against the skin S.For example, in some embodiments, the contact surface 220 can include alayer of adhesive (not shown in FIGS. 4-7). In other embodiments, theanchor portion 228 can include straps, fasteners and/or any othersuitable mechanism for limiting movement of the target member 210relative to the body B (not shown in FIGS. 4-7).

A target probe 214 is movably coupled to the target member 210. In someembodiments, for example, the target probe 214 can be slidably disposedwithin a lumen (not shown in FIGS. 4-7) defined by target member 210. Inother embodiments, the target probe 214 can be slidably disposed againstan outer surface of the target member 210. The target probe 214 has aproximal end portion 215 and a distal end portion 216 (see e.g., FIG.6). The proximal end portion 215 includes multiple graduated markings218 that indicate the position of the target probe 214 relative to thetarget member 210. Similarly stated, the graduated markings 218 of theproximal end portion 215 can indicate the distance between the distalend portion 216 of the target probe 214 and the distal end portion 213of the target member 210. In this manner, as shown in FIG. 5, thegraduated markings 218 can indicate the depth D of the insertion of thetarget probe 214.

The insertion member 240 has a proximal end portion 242 and a distal endportion 243. As shown in FIG. 5, the insertion member 240 is curved suchthat at least a portion of the insertion member 240 is characterized bya radius of curvature R. As described in more detail below, the curvedshape of the insertion member 240 contributes to the trajectory of thepassageway formed by the insertion member 240 when the insertion member240 is inserted into the body B. In some embodiments, the center pointof the radius of curvature R is coincident with the coupling joint 265.In other embodiments, however, the center point of the radius ofcurvature R can be offset from the coupling joint 265. Similarly, insome embodiments the radius of curvature R can be substantially the sameas the length L₂ of the coupling member 264. In other embodiments,however, the radius of curvature R can be different from the length L₂of the coupling member 264.

The distal end portion 243 of the insertion member 240 is selectivelycoupled to an implant 202. The selective coupling of the distal endportion 243 of the insertion member 240 and the implant 202 can beaccomplished by any suitable means, as described above. The implant 202includes a distal end 205 configured to extend from distal end portion243 of the insertion member 240. The distal end portion 205 of theimplant 202 is tapered such that the distal end portion 205 can pierce,dilate and/or displace bodily tissue. As shown in FIG. 7, a lead wire206 is coupled to the proximal end portion of the implant 202. Asdescribed above, the implant 202 can be an electronic implant, such as,for example, a microstimulator, an elongate implant, an electronic lead,an electrode, a power supply, an amplifier and/or a sensor.

The proximal end portion 242 of the insertion member 240 includes anactuator 244 configured to selectively couple and/or decouple the distalend portion 243 of the insertion member 240 from the implant 202. Inthis manner, as described in more detail herein, when the implant 202 isdisposed within the body B adjacent the target tissue T, a user canactuate the actuator 244 to decouple the distal end portion 243 of theinsertion member 240 from the implant 202. Similarly, the user canactuate the actuator 244 to couple the distal end portion 243 of theinsertion member to the implant 202 to facilitate removal of the implant202 from the body B and/or repositioning the implant 202 within the bodyB. The actuator 244 can be any suitable actuator, such as for example, amechanical actuator, an electrical actuator, a hydraulic actuator, apneumatic actuator or the like.

The insertion member 240 is rotatably coupled to the target member 210by the coupling member 264, which includes a first end portion 266 and asecond end portion 267. The first end portion 266 of the coupling member264 is rotatably coupled to the proximal end portion 212 of the targetmember 210 at the coupling joint 265. In this manner, the couplingmember 264, and therefore the insertion member 240, can rotate relativeto the target member 210 about the coupling joint 265. Said another way,the coupling member 264 can rotate relative to the target member 210 tochange the angle α between the coupling member 264 and the target member210. Similarly, the second end portion 267 of the coupling member 264 isrotatably coupled to the proximal end portion 242 of the insertionmember 240. In this manner, the insertion member 240 can rotate relativeto the target member 210 independent from the rotation of the couplingmember 264 relative to the target member 210. Said another way, theinsertion member 240 can rotate relative to the coupling member 264 tochange the angle Θ between the insertion member 240 and the couplingmember 264.

As shown in FIG. 5, the second end portion 267 of the coupling member264 includes multiple graduated markings 268 and is movably coupled tothe first end portion 266 of the coupling member 264. In this manner,the length L₂ of the coupling member 264 can be changed during theoperation of the medical device 200. Although the second end portion 267of the coupling member 264 is shown as being slidably disposed within aportion of the first end portion 266 of the coupling member, in otherembodiments, the second end portion 267 and the first end portion 266can be movably coupled together in any suitable arrangement.

As shown in FIG. 4, the medical device 200 can be placed in the firstconfiguration by disposing the distal end portion 213 of the targetmember 210 against the body B. When the medical device 200 is in thefirst configuration, the contact surface 220 can engage the skin S tomaintain a position of the target portion 210 relative to the skin S. Inthis manner, after the user determines the appropriate position on thebody B for insertion of the target probe 214, the target member 210 canbe securely positioned against the body B.

When the medical device 200 is in the first configuration, the distalend portion 243 of the insertion member 240 is coupled to the implant202. Additionally, the insertion member 240 is in a first positionrelative to the target member 210 and/or the coupling member 264 suchthat the distal end portion 243 of the insertion member 240 is disposedoutside of the body B. Similarly stated, when the medical device 200 isin the first configuration, the coupling member 264 is angularly offsetfrom the target member 210 by a first angle α₁ and the insertion member240 is angularly offset from the coupling member 264 by a first angleΘ₁. In some embodiments, the medical device 200 can be maintained in itsfirst configuration by a ratchet mechanism, a detent, a biasing member,a locking mechanism and/or the like.

As shown in FIG. 5, the medical device 200 can be placed in the secondconfiguration by inserting the distal end portion 216 of the targetprobe 214 into the body B, by changing the length L₂ of the couplingmember 264, and/or by rotating the insertion member 240 relative to thecoupling member 264. The distal end portion 216 of the target probe 214is inserted by moving the target probe 214 relative to the target member210, as shown by arrow CC. In this manner, the insertion of the targetprobe 214 is guided by the target member 210. The target probe 214 ismoved relative to the target member 210 such that the distal end portion216 of the target probe 214 is inserted through and/or defines a firstincision (not identified in FIG. 5) in the skin S. As described above,the target probe 214 is moved within the body B along a first passageway(not identified in FIG. 5) such that the distal end portion 216 of thetarget probe 214 is adjacent the target tissue T. Similarly stated, thedistal end portion 216 of the target probe 214 is inserted along and/ordefines a first passageway to a predetermined depth D within the body B.As described above, the magnitude of the depth D can be indicated by thegraduated markings 218 of the proximal end portion 215 of the targetprobe 214.

The length L₂ of the coupling member 264 can be changed by moving thesecond end portion 267 relative to the first end portion 266, as shownby arrow DD in FIG. 5. The length L₂ of the coupling member 264 can beindicated using the graduated markings 268. In some embodiments, thecoupling member 264 can be maintained at a predetermined length L₂ by adetent, a biasing member, a locking mechanism and/or the like.Similarly, the insertion member 240 can be rotated relative to thecoupling member 264 such that the insertion member 240 is angularlyoffset from the coupling member 264 by an angle Θ₂ that is differentfrom the angle Θ₁. The orientation of the insertion member 240 relativeto the coupling member 264 can be maintained by a detent, a biasingmember, a locking mechanism and/or the like. By adjusting the length L₂of the coupling member 264 and/or the angle between the insertion member240 and the coupling member 264, the user can define a predeterminedlocation for the incision and/or a predetermined trajectory of thepassageway P₂ through which the distal end portion 243 of the insertionmember 240 will be inserted into the body B.

In some embodiments, locating the target tissue T with the target probe214 can be an iterative process. Accordingly, in some embodiments, thedistal end portion 216 can be inserted into the body before the distalend portion 213 of the targeting member 210 is disposed against the bodyB. In this manner, the target tissue T can be located before the contactsurface 220 is placed against and/or anchored to the skin S. In suchembodiments, after the distal end portion 216 of the target tissue 214is disposed adjacent the target tissue T, the target member 210 is movedabout the target probe 214 until the contact surface 220 is disposedagainst the skin S.

When the distal end portion 216 of the target probe 214 is adjacent thetarget tissue T and the length L₂ of the coupling member 264 and/or theangle Θ between the insertion member 240 and the coupling member 264 areadjusted, the insertion member 240 can be rotated relative to the targetmember 210 as shown by the arrow EE in FIG. 6. In this manner, themedical device 200 can be moved between the second configuration and thethird configuration. When the medical device 200 is in the thirdconfiguration, the insertion member 240 is in a second position relativeto the target member 210 such that the distal end portion 243 of theinsertion member 240 is disposed within the body B. Similarly stated,when the medical device 200 is in the second configuration, theinsertion member 240 is angularly offset from the target member 210 by asecond angle α₂.

When the medical device 200 is moved between the second configuration(FIG. 5) and the third configuration (FIG. 6), the distal end portion243 of the insertion member 240 is inserted into the body B through asecond incision I₂ in the skin S. The distal end portion 243 of theinsertion member 240 is moved within the body B via a second passagewayP₂ such that the distal end portion 243 of the insertion member 240 isadjacent the target tissue T and/or the distal end portion 216 of thetarget probe 214. When the medical device 200 is moved between thesecond configuration and the third configuration, the distal end portion243 of the insertion member 240 remains coupled to the implant 202.Accordingly, when the medical device 200 is moved between the secondconfiguration and the third configuration, the implant 202 is moved froma region outside of the body to a region within the body B.

As described above, the length L₂ of the coupling member 264 and/or theangle Θ between the insertion member 240 and the coupling member 264 canbe adjusted based on the depth D of the target probe 214. In thismanner, the second incision I₂ through which the distal end portion 243of the insertion member 240 is disposed and/or the trajectory of thesecond passageway P₂ through which the distal end portion 243 of theinsertion member 240 travels within the body B can be adjusted asdesired. Similarly stated, the kinematic relationship between the targetmember 210, the coupling member 264 and/or the insertion member 240allows the distal end portion 243 of the insertion member 240 to beinserted into the body B along multiple different passageways, each ofwhich can terminate at the target tissue T. For example, in someembodiments, the medical device 200 can be adjusted to result in a largespacing between the first incision (not identified in FIGS. 4-7) and thesecond incision I₂ and a passageway having a shallow angle of entry intothe body B. In other embodiments, however, the medical device 200 can beadjusted to result in a small spacing between the first incision and thesecond incision I₂ and a passageway having a steeper angle of entry intothe body B.

When the distal end portion 243 of the insertion member 240 and/or theimplant 202 is adjacent the target tissue T, the distal end portion 243of the insertion member 240 can be decoupled from the implant 202 usingthe actuator 244. The insertion member 240 can then be rotated relativeto the target member 210 as shown by the arrow FF in FIG. 7, therebyplacing the medical device 200 in the fourth configuration. When themedical device 200 is moved between the third configuration (FIG. 6) andthe fourth configuration (FIG. 7), the distal end portion 243 of theinsertion member 240 is removed from within the body B via the secondpassageway P₂ and the second incision I₂, while the implant 202 remainswithin the body B. The lead wire 206 can extend from the body B throughthe second passageway P₂.

The distal end portion 243 of the insertion member 240 can be coupled tothe implant 202 in any suitable manner that allows the selectivecoupling and/or decoupling of the distal end portion 243 and the implant202, both within the body B and outside of the body B. For example, insome embodiments, the distal end portion 243 of the insertion member 240can define a lumen configured to receive the implant 202. In thismanner, the side wall insertion member 240 can prevent the implant 202from contacting portions of the patient's body B during insertion. Saidanother way, when the medical device 200 is moved from the secondconfiguration to the third configuration, the insertion member 240 canprevent the implant 202 from being damaged during insertion.

The target probe 214 can include any suitable target probe for locatingthe target tissue T within the body B. For example, in some embodiments,the target probe 214 can be a needle, a guide wire or the likeconfigured to locate the target tissue T by mechanically stimulating abodily tissue. In other embodiments, the target probe 214 can be aradio-opaque targeting probe configured to locate the target tissue T inconjunction with an imaging system. In yet other embodiments, thetargeting probe 214 can include an electrode configured to convey anelectrical signal between the target tissue T and an electrical device(not shown in FIGS. 4-7) disposed outside of the body B. For example, insome embodiments, the target probe 214 can be an electromyogram (EMG)needle configured to be percutaneously inserted into the body B toelectrically stimulate and/or receive an electronic signal from thetarget tissue T. In some embodiments, the target probe 214 can be an EMGneedle having a length of 25 mm to 75 mm and a diameter of 25 gage to 28gage. In other embodiments, the target probe 214 can be an EMG needlehaving a diameter of 0.9 mm and length of 20-25 cm.

Although the insertion member 240 of the medical device 200 is shown asincluding a single structure configured to pierce the skin S, define thesecond passageway P2, and/or convey the implant 202 to the target tissueT, in other embodiments, an insertion member can include multiplecomponents to perform the various functions described herein. Forexample, FIGS. 8-10 are partial cross-sectional side views of an implantinsertion device 300 according to an embodiment of the invention. Theimplant insertion device 300 includes a target member 310, an insertionmember 340, a first coupling member 364, and a second coupling member365.

The target member 310 has a proximal end portion 312 and a distal endportion 313. The distal end portion 313 includes a target probe 314configured to locate a target tissue T within the body B. For example,as described above, in some embodiments, the target probe 314 can be anelectronic stimulating probe having an exposed electrode configured tostimulate and/or receive an electronic signal from a muscle, nerve orthe like to locate the target tissue T. The distal end portion 313 ofthe target member 310 also includes an anchor portion 328 having acontact surface 320 configured to be disposed against the skin S of abody B when the distal tip 316 of the target probe 314 is adjacent thetarget tissue T. In this manner, the position of the target member 310relative to the body B can be maintained throughout the operation of theimplant insertion device 300.

The insertion member 340 includes a sheath 352 and a dilator 354, eachof which are independently and movably coupled to the target member 310,as described in more detail below. The sheath 352 includes a proximalend portion 342 and a distal end portion 343 and defines a lumen 353therethrough. The sheath 352 has a curved shape, which can characterizethe trajectory of the insertion passageway formed in the body, asdescribed above. The sheath 352 is rotatably coupled to the targetmember 310 by the first coupling member 364, which includes a first endportion 366 and a second end portion 367. The first end portion 366 ofthe first coupling member 364 is rotatably coupled to the proximal endportion 312 of the target member 310 via any suitable coupling joint atlocation 365. The second end portion 367 of the first coupling member364 is coupled to the proximal end portion 342 of the sheath 352.

The dilator 354 includes a proximal end portion 355 and a distal endportion 356. The distal end portion 356 of the dilator 354 is taperedsuch that the distal end portion 356 can pierce, dilate and/or displacebodily tissue. Said another way, the distal end portion 356 of thedilator 354 is configured to define an incision and/or a passagewaywithin the body B through which an implant can be inserted. As shown inFIGS. 8 and 10, at least a portion of the dilator 354 is configured tobe disposed within the lumen 353 of the sheath 352. Similarly stated,the dilator 354 has a curved shape that corresponds to the curved shapeof the sheath 352.

The dilator 354 is rotatably coupled to the target member 310 by thesecond coupling member 365, which includes a first end portion 371 and asecond end portion 372. The first end portion 371 of the second couplingmember 365 is rotatably coupled to the proximal end portion 312 of thetarget member 310 via any suitable coupling joint at location 365. Thesecond end portion 372 of the second coupling member 365 is coupled tothe proximal end portion 355 of the dilator 354. In this manner, thedilator 354 can rotate relative to the target member 310 about thelocation 365 independently from the rotation of the sheath 352 relativeto the target member 310. Although the sheath 352 and the dilator 354are both shown as being rotatably coupled to the proximal portion 312 ofthe target member 310 at location 365, in other embodiments, the sheath352 and the dilator 354 can be rotatably coupled to the target member310 at different locations and/or via different coupling joints.

As shown in FIG. 8, the implant insertion device 300 can be placed in afirst configuration by disposing the target probe 314 into the body Bsuch that the distal tip 316 of the target probe 314 is adjacent thetarget tissue T. Said another way, when the implant insertion device 300is in the first configuration, the distal tip 316 of the target probe314 is positioned at a predetermined location (e.g., proximate aparticular anatomical structure, at a desired depth or the like) withinthe patient's body B. Moreover, when the implant insertion device 300 isin the first configuration, the contact surface 320 of the anchoringportion 328 can engage the skin S to maintain a position of the targetportion 310 relative to the skin S.

When the implant insertion device 300 is in the first configuration, thedilator 354 is disposed within the sheath 352 such that the distal endportion 356 of the dilator 354 is disposed outside of the distal endportion 343 of the sheath 352. In this manner, the sheath 352 and thedilator 356 can be rotated simultaneously relative to the target portion310 such that the distal end portion 343 of the sheath 352 and thedistal end portion 356 of the dilator 354 are moved from a locationoutside of the body B to a location within the body B adjacent thetarget tissue T, as shown in FIG. 8. Said another way, when the implantinsertion device 300 is in the first configuration, the sheath 352 andthe dilator 354 can be rotated relative to the target portion 310 whilemaintaining the position of the dilator 354 within the sheath 352. Inthis manner, the sheath 352 and the dilator 354 can cooperatively definean incision (not identified in FIGS. 8-10) in the skin S and/or apassageway (not identified in FIGS. 8-10) within the body B. In someembodiments, the position of the dilator 354 within the sheath 352 canbe maintained by a detent, a biasing member, a locking mechanism and/orthe like.

As shown in FIG. 9, the implant insertion device 300 can be placed inthe second configuration by rotating the dilator 354 relative to thetarget portion 310 as shown by the arrow GG such that the dilator 354 isdisposed entirely outside of the lumen 353 of the sheath 352. Saidanother way, when the implant insertion device 300 is moved between thefirst configuration and the second configuration, the dilator 354 isrotated relative to the target portion 310 while the sheath 352 remainsat a constant position relative to the target portion 310. Said yetanother way, when the implant insertion device 300 is moved between thefirst configuration and the second configuration, the dilator 354 isrotated relative to the target portion 310 independently from the sheath352.

When the implant insertion device 300 is in the second configuration, animplant 302 is disposed within the lumen 353 of the sheath 352 at theproximal end portion 342 of the sheath 352. The implant 302 includes aproximal end portion 303 and a distal end portion 305. As shown in FIG.9, the distal end portion 305 of the implant 302 is disposed first intothe lumen 353 and is tapered such that the distal end portion 305 canpierce, dilate and/or displace bodily tissue. As described above, theimplant 302 can be an electronic implant, such as, for example, amicrostimulator, an elongate implant, an electronic lead, an electrode,a power supply, an amplifier and/or a sensor.

When the implant insertion device 300 is moved between the secondconfiguration (FIG. 9) and the third configuration (FIG. 10), thedilator 354 is rotated relative to the target portion 310 as shown bythe arrow HH in FIG. 10. In this manner, the distal end portion 356 ofthe dilator 354 is disposed within the lumen 353 of the sheath 354 andis in contact with the proximal end 303 of the implant 302. Accordingly,the movement of the dilator 354 within the sheath 352 causes the implant302 to move within the lumen 353 until the implant 302 is disposedwithin the body B outside of the sheath. Said another way, when theimplant insertion device 300 is moved between the second configurationand the third configuration, the implant 302 is moved from a locationoutside of the body B to a location within the body B adjacent thetarget tissue T via the sheath 352. In this manner, the sheath 352 canprevent the implant 302 from contacting bodily tissue during theinsertion process, thereby reducing the likelihood that the implant 302will be damaged during the insertion process.

Although the insertion members of the medical devices shown anddescribed above are shown as being rotatably coupled to a target memberof the medical device, in other embodiments, an insertion member can bymovably coupled to a target member in any suitable fashion. For example,in some embodiments, an insertion member can be coupled to a targetmember such that the insertion member can translate with respect to thetarget member. For example, FIGS. 11-13 are front views of a medicaldevice 400 according to an embodiment of the invention in a firstconfiguration, a second configuration, and a third configuration,respectively. The medical device 400 includes a target member 410, aninsertion member 440, and a coupling member 464. The target member 410has a proximal end portion 412 and a distal end portion 413. The distalend portion 413 includes a target probe 414 of the types describedherein configured to locate a target tissue T within the body B. Forexample, in some embodiments, the target probe 414 can be an electronicstimulating probe having an exposed electrode configured to stimulate amuscle, a nerve or the like and/or receive an electronic signal from amuscle, nerve or the like to locate the target tissue T.

The insertion member 440 has a proximal end portion 442 and a distal endportion 443. The distal end portion 443 of the insertion member 440 isselectively coupled to an implant 402. The selective coupling of thedistal end portion 443 of the insertion member 440 and the implant 402can be accomplished by any suitable means, as described above. Theimplant 402 includes a distal end 405 configured to extend from distalend portion 443 of the insertion member 440. The distal end portion 405of the implant 402 is tapered such that the distal end portion 405 canpierce, dilate and/or displace bodily tissue. As described above, theimplant 402 can be an electronic implant, such as, for example, amicrostimulator, an elongate implant, an electronic lead, an electrode,a power supply, an amplifier and/or a sensor.

The proximal end portion 442 of the insertion member 440 includes anactuator 444 configured to selectively couple and/or decouple the distalend portion 443 of the insertion member 440 from the implant 402. Asdescribed above, the actuator 444 can be any suitable actuator, such asfor example, a mechanical actuator, an electrical actuator, a hydraulicactuator, a pneumatic actuator or the like.

The proximal end portion 442 of the insertion member 440 is movablycoupled to the target member 410 by the coupling member 464, whichincludes a first end portion 466 and a second end portion 467. The firstend portion 466 of the coupling member 464 is rotatably coupled to theproximal end portion 412 of the target member 410 at the coupling joint465. In this manner, the coupling member 464, and therefore theinsertion member 440, can rotate relative to the target member 410 aboutthe coupling joint 465, as shown by the arrow II in FIG. 11. Saidanother way, the coupling member 464 can rotate relative to the targetmember 410 to change the angle α (identified in FIG. 11) between thecoupling member 464 and the target member 410.

Similarly, the second end portion 467 of the coupling member 464 ismovably coupled to the proximal end portion 442 of the insertion member440 such that the insertion member 440 can translate and rotate relativeto the target member 410 and/or the coupling member 464. In this manner,the insertion member 440 can rotate relative to the target member 410independent from the rotation of the coupling member 464 relative to thetarget member 410, as shown by the arrow JJ in FIG. 11. Similarlystated, the insertion member 440 can rotate relative to the couplingmember 464 to change the angle Θ (identified in FIG. 11) between theinsertion member 440 and the coupling member 464. Moreover, as describedin more detail below, the insertion member 440 can translate relative tothe target member 410 and/or the coupling member 464 as shown by arrowKK in FIG. 12. Similarly stated, the insertion member 440 can moverelative to the target member 410 and/or the coupling member 464 withoutthe angular orientation of the insertion member 440 relative to thetarget member 410 and/or the coupling member 464 changing.

As shown in FIG. 11, the medical device 400 can be placed in the firstconfiguration by inserting the distal end portion 413 of the targetmember 410 into the body B through a first incision I₁ in the skin S.The distal end portion 413 is inserted via a first passageway P₁ suchthat the distal tip 416 of the target probe 414 is adjacent the targettissue T. When the medical device 400 is in the first configuration, thedistal end portion 443 of the insertion member 440 is coupled to theimplant 402. Additionally, the insertion member 440 is in a firstposition relative to the target member 410 and/or the coupling member464 such that the distal end portion 443 of the insertion member 440 isdisposed outside of the body B. Similarly stated, when the medicaldevice 400 is in the first configuration, the coupling member 464 is atan angular orientation relative to the target member 410 as defined bythe angle α and the insertion member 440 is at an angular orientationrelative to the coupling member 464 as defined by the angle Θ. Theangular orientation of the insertion member 440 relative to the targetmember 410 can be adjusted and/or maintained, as described above. Inthis manner, the user can define a predetermined location for theincision and/or a predetermined trajectory of the passageway P₂ throughwhich the distal end portion 443 of the insertion member 440 will beinserted into the body B.

The medical device 400 can be moved from the first configuration (FIG.11) to the second configuration (FIG. 12) by translating the insertionmember 440 relative to the coupling member 464 and/or the target member410, as shown by the arrow KK in FIG. 12. Said another way, the medicaldevice 440 can be moved from the first configuration to the secondconfiguration by moving the insertion member 440 relative to thecoupling member 464 such that the angular orientation of the insertionmember 440 relative to the coupling member 464 does not change. When themedical device 400 is moved between the first configuration and thesecond configuration, the distal end portion 443 of the insertion member440 is inserted into the body B through a second incision I₂ in the skinS. The distal end portion 443 of the insertion member 440 is movedwithin the body B via a second passageway P₂ such that the distal endportion 443 of the insertion member 440 is adjacent the target tissue Tand/or the distal end portion 416 of the target probe 414. Accordingly,when the medical device 400 is moved between the first configuration andthe second configuration, the implant 402 is moved from a region outsideof the body to a region within the body B.

When the distal end portion 443 of the insertion member 440 and/or theimplant 402 is adjacent the target tissue T, the distal end portion 443of the insertion member 440 can be decoupled from the implant 402 usingthe actuator 444. The insertion member 440 can then be translatedrelative to the target member 410 and/or the coupling member 464 asshown by the arrow LL in FIG. 13, thereby placing the medical device 400in the third configuration. When the medical device 400 is moved betweenthe second configuration (FIG. 12) and the third configuration (FIG.13), the distal end portion 443 of the insertion member 440 is removedfrom within the body B via the second passageway P₂ and the secondincision I₂, while the implant 402 remains within the body B.

Although the insertion member 440 is shown and described above as beingmovably coupled to the coupling member 464, in other embodiments, amedical device 440 can include an insertion member 440 that can beslidably disposed within and/or removably coupled to a coupling member464. For example, FIGS. 14 and 15 are partial cross-sectional frontviews of a medical device 500 according to an embodiment of theinvention. The medical device 500 includes a target member 510, aninsertion tool 540, an insertion guide member 541, and a coupling member564. The target member 510 has a proximal end portion 512 and a distalend portion 513. The distal end portion 513 includes a target probe 514of the types described herein configured to locate a target tissue Twithin the body B.

The insertion guide member 541 defines a lumen 548 therethrough. Thelumen 548 defines a center line CL. As described in more detail herein,the lumen 548 is configured to receive a portion of the insertion tool540. The insertion guide member 541 is movably coupled to the targetmember 510 by the coupling member 564, which includes a first endportion 566 and a second end portion 567. The first end portion 566 ofthe coupling member 564 is rotatably coupled to the proximal end portion512 of the target member 510 at the coupling joint 565. In this manner,the coupling member 564, and therefore the insertion tool 540, canrotate relative to the target member 510 about the coupling joint 565,as shown by the arrow MM in FIG. 14. Said another way, the couplingmember 564 can rotate relative to the target member 510 to change theangle α (identified in FIG. 14) between the coupling member 564 and thetarget member 510.

Similarly, the second end portion 567 of the coupling member 564 isrotatably coupled to the insertion guide member 541. In this manner, theinsertion guide member 541 can rotate relative to the target member 510independent from the rotation of the coupling member 564 and relative tothe target member 510, as shown by the arrow NN in FIG. 14. Similarlystated, the insertion guide member 541 can rotate relative to thecoupling member 564 to change the angle Θ (identified in FIG. 14)between the insertion guide member 541 and the coupling member 564.

The insertion tool 540 has a proximal end portion 542 and a distal endportion 543. The distal end portion 543 of the insertion tool 540 isselectively coupled to an implant 502. The selective coupling of thedistal end portion 543 of the insertion tool 540 and the implant 502 canbe accomplished by any suitable means, as described above. As describedabove, the implant 502 can be an electronic implant, such as, forexample, a microstimulator, an elongate implant, an electronic lead, anelectrode, a power supply, an amplifier and/or a sensor. The proximalend portion 542 of the insertion tool 540 includes an actuator 544configured to selectively couple and/or decouple the distal end portion543 of the insertion tool 540 from the implant 502. As described above,the actuator 544 can be any suitable actuator, such as for example, amechanical actuator, an electrical actuator, a hydraulic actuator, apneumatic actuator or the like.

As shown in FIG. 14, the medical device 500 can be placed in the firstconfiguration by inserting the distal end portion 513 of the targetmember 510 into the body B through a first incision I₁ in the skin S.The distal end portion 513 is inserted via a first passageway P₁ suchthat the distal tip 516 of the target probe 514 is adjacent the targettissue T. When the medical device 500 is in the first configuration, theinsertion guide member 541 is in a predetermined position and/or angularorientation relative to the coupling member 564 and/or the target member510. Similarly stated, when the medical device 500 is in the firstconfiguration, the coupling member 564 is at an angular orientationrelative to the target member 510 as defined by the angle α and theinsertion guide member 541 is at an angular orientation relative to thecoupling member 564 by the angle Θ. In this manner, the user can definea predetermined location for the incision and/or a predeterminedtrajectory of the passageway P₂ through which the distal end portion 543of the insertion tool 540 will be inserted into the body B.

When the medical device 500 is in the first configuration, the insertiontool 540 is decoupled from the insertion guide member 541. Said anotherway, the when the medical device 500 is in the first configuration, theinsertion tool 540 is disposed outside of the lumen 548 defined by theinsertion guide member 541.

The medical device 500 can be moved from the first configuration (FIG.14) to the second configuration (FIG. 15) by inserting the distal endportion 543 of the insertion tool 540 within the lumen 548 and slidingthe insertion tool 540 distally as shown by the arrow OO in FIG. 15.Said another way, the medical device 540 can be moved from the firstconfiguration to the second configuration by translating at least aportion of the insertion tool 540 within the insertion guide member 541.When the medical device 500 is moved between the first configuration andthe second configuration, the distal end portion 543 of the insertiontool 540 is inserted into the body B through a second incision I₂ in theskin S. The distal end portion 543 of the insertion tool 540 is movedwithin the body B via a second passageway P₂ such that the distal endportion 543 of the insertion tool 540 is adjacent the target tissue Tand/or the distal end portion 516 of the target probe 514. Accordingly,when the medical device 500 is moved between the first configuration andthe second configuration, the implant 502 is moved from a region outsideof the body to a region within the body B.

When the distal end portion 543 of the insertion tool 540 and/or theimplant 502 is adjacent the target tissue T, the distal end portion 543of the insertion tool 540 can be decoupled from the implant 502 usingthe actuator 544. The insertion tool 540 can then be translated relativeto the insertion guide member 541 to remove the distal end portion 543of the insertion tool 540 from the body B

FIGS. 16-18 are cross-sectional front views of a target device 600according to an embodiment of the invention, in a first configuration, asecond configuration and a third configuration, respectively. The targetdevice 600 includes a target portion 610 and an insertion portion 664.The target portion 610 of the target device 600 includes a contactsurface 620 configured to be disposed against and/or anchored to theskin of a body (not shown in FIGS. 16-18). The target portion 610 of thetarget device 600 defines a first lumen 622 having a center line CL₁.

The insertion portion 664 of the target device 600 includes an insertionguide member 641. The insertion guide member 641 defines a second lumen648 having a center line CL₂. At least a portion of the insertion guidemember 641 is disposed within a cavity 624 defined by the insertionportion 664 of the target device 600 such that the insertion guidemember 641 can rotate relative to the target device 600, as shown by thearrow QQ in FIG. 17. Said another way, the insertion can rotate relativeto the target device 600 such that an angle β between the center lineCL₁ of the first lumen 622 and the center line CL₂ of the second lumen648 can be changed. Said yet another way, the insertion guide member 641is configured to rotate within the cavity 624 about an axissubstantially normal to the center line CL₁ and/or the center line CL₂.Although the insertion guide member 641 is shown in FIGS. 16 and 17 asrotating about a single axis, in other embodiments, the insertion guidemember 641 can rotate about multiple axes. For example, in someembodiments, the insertion guide member 641 can have a spherical shapethat corresponds to a spherical shape of the cavity 624 (i.e., theinsertion guide member 641 and the cavity 624 can form a ball-and-socketjoint).

In use, the target device 600 can be placed against the body (not shownin FIGS. 16-18) to guide the insertion of an implant. As shown in FIG.17, when the target device 600 is in the second configuration, a targetprobe 610 of the types shown and described herein can be disposed withinthe first lumen 622 such that a distal tip (not shown in FIGS. 16-18) ofthe target probe 614 extends distally outside of the first lumen 622.Similarly stated, when the target device 600 is in the secondconfiguration, a portion of the target probe 614 is disposed within thefirst lumen 622 such that the distal tip of the target probe 614 isdisposed outside of the first lumen 622 on the distal side of the targetdevice 600 and a proximal end portion 615 of the target probe 614 isdisposed outside of the first lumen 622 on the proximal side of thetarget device 600.

The target probe 614 is configured to move within the first lumen 622 asshown by the arrow PP in FIG. 17. Similarly stated, when the targetdevice 600 is moved from the first configuration (FIG. 16) to the secondconfiguration (FIG. 17), the target probe 614 is moved within the firstlumen 622 along the center line CL₁. Accordingly, in a similar manner asdescribed above, a portion of the target probe 614 can be inserted intothe body such that the distal tip of the target probe 614 is adjacent toa target tissue (not shown in FIGS. 16-18). Said another way, when thetarget probe 614 is inserted into the body, the target device 614 isguided by the first lumen 622 of the target device 600.

The proximal end portion 615 includes multiple graduated markings 618that indicate the position of the target probe 614 relative to thetarget portion 610 of the target device 600. Similarly stated, thegraduated markings 618 of the proximal end portion 615 can indicate thedistance between the distal tip of the target probe 614 and the contactsurface 620 of the target device 600. In this manner, as described abovewith reference to FIG. 5, the graduated markings 618 can indicate thedepth of the insertion of the target probe 614.

As described above, in some instances, locating the target tissue withthe target probe 614 can be an iterative process. Accordingly, in someembodiments, the distal tip of the target probe 614 can be inserted intothe body before target probe 614 is disposed within the first lumen 622.In this manner, the target tissue can be located before the contactsurface 620 is placed against and/or anchored to the skin. In suchembodiments, after the distal tip of the target probe 614 is within thebody, the target device 600 can be moved about the target probe 614until the contact surface 620 is disposed against the body.

When the target device 600 is moved between the first configuration andthe second configuration, the insertion guide member 641 is rotated suchthat the angle between the center line CL₁ of the first lumen 622 andthe center line CL₂ of the second lumen 648 is changed from β₁ to β₂. Insome embodiments, the magnitude of the rotation of the insertion guidemember 641 can be indicated by a series of graduated markings (not shownin FIGS. 16-18) on the surface of the insertion guide member 641.

The target device 600 can be moved from the second configuration (FIG.17) to the third configuration (FIG. 18) by inserting a portion of aninsertion tool 640 into the second lumen 648. Said another way, when thetarget device 600 is moved from the second configuration to the thirdconfiguration, at least a portion of the insertion tool 640 istranslated relative to the target device 600 as shown by the arrow RR inFIG. 18. Similarly stated, when the target device 600 is moved from thesecond configuration to the third configuration, the movement of theinsertion tool 640 is guided by the second lumen 648 of the targetdevice 600.

The insertion tool 640 can be similar to the insertion tools shown anddescribed above, and can include a distal end portion (not shown in FIG.18) configured to be selectively coupled to an implant (not shown inFIG. 18). The insertion tool 640 also includes a proximal end portion642 that includes an actuator 644 of the types shown and describedabove. Accordingly, when the insertion tool 640 is moved within thesecond lumen 648, the distal end portion of the insertion tool 640 canbe inserted into the body. The distal end portion of the insertion tool640 can be moved within the body B such that the distal end portion ofthe insertion tool 640 is adjacent the target tissue and/or the distaltip of the target probe 614. Accordingly, when the target device 600 ismoved between the second configuration and the third configuration, theimplant can be moved from a region outside of the body to a regionwithin the body B.

Although the insertion guide member 641 of the target device 600 isshown as being movable relative to the target portion 610 of the guidemember 600, in other embodiments, a target device can include aninsertion guide portion that maintained in a fixed position and/ororientation. For example, FIG. 19 is a cross-sectional view of a targetdevice 700 according to an embodiment of the invention. The targetdevice 700 includes a target portion 710 and an insertion portion 764.The target portion 710 of the target device 700 includes a contactsurface 720 configured to be disposed against and/or anchored to theskin of a body (not shown in FIG. 19). The target portion 710 of thetarget device 700 defines a first lumen 722 having a center line CL₁.

The insertion portion 764 of the target device 700 defines a secondlumen 748, a third lumen 749, and a fourth lumen 750. The second lumenhas a center line CL₂ that is angularly offset from the center line CL₁by a constant angle β₁. Said another way, the center line CL₂ is nonparallel to the center line CL₁. Similarly, the third lumen has a centerline CL₃ that is angularly offset from the center line CL₁ by a constantangle β₂ that is different from the angle β₁. Said another way, thecenter line CL₃ is non parallel to the center lines CL₁ and CL₂.Similarly, the fourth lumen has a center line CL₄ that is angularlyoffset from the center line CL₁ by a constant angle β₃ that is differentfrom the angles β₁ and β₂. Said another way, the center line CL₄ is nonparallel to the center lines CL₁, CL₂, and CL₃.

In use, the target device 700 can be placed against the body (not shownin FIG. 19) and used to guide the insertion of a target probe and aninsertion tool in a similar manner as described above with reference toFIGS. 16-18. More particularly, the first lumen 722 can receive and/orguide the insertion of the target probe into the body. The insertiontool can inserted into the body via any one of the second lumen 748, thethird lumen 749, and/or the fourth lumen 750 according to the desiredinsertion location and/or trajectory of insertion path.

FIGS. 20 and 21 are schematic illustrations of a medical device 800according to an embodiment of the invention in a first configuration anda second configuration, respectively. The medical device 800 includes atarget member 810, an insertion member 840, and an electronic circuitsystem 880. The target member 810 has a proximal end portion 812 and adistal end portion 813. The distal end portion 813 includes a targetprobe 814 configured to locate a target tissue T within the body B. Forexample, in some embodiments, the target probe 814 can be an electronicstimulating probe having an exposed electrode configured to stimulate amuscle, a nerve or the like and/or receive an electronic signal from amuscle, nerve or the like to locate the target tissue T.

The insertion member 840 has a proximal end portion 842 and a distal endportion 843. The distal end portion 843 of the insertion member 840 isconfigured to be selectively coupled to an implant 802, as describedabove. In some embodiments, for example, the implant 802 can be anelectronic implant, such as, for example, a microstimulator, an elongateimplant, an electronic lead, an electrode, a power supply, an amplifierand/or a sensor. In other embodiments, the implant 802 can be devoid ofelectronic circuitry, such as, for example, a drug-eluting implant. Theproximal end portion 842 of the insertion member 840 is rotatablycoupled to the proximal end portion 812 of the target member 810 at acoupling joint 865. In this manner, the insertion member 840 can rotaterelative to the target member 810 about the coupling joint 865.Accordingly, the medical device 800 is configured to insert the implant802 into the body B, as described above.

The electronic circuit system 880 is coupled to the proximal end portion842 of the insertion member 840. The electronic circuit system 880 isconfigured to produce an electronic signal 881 proportional to thedistance between the distal end portion 843 of the insertion member 840and the distal end portion 814 of the target member 810, as described inmore detail herein. The electronic signal 881 can include a visualoutput, an audible output and/or a haptic output. For example, in someembodiments, the electronic signal 881 can be associated with an audiblemessage informing a user of the distance between the distal end portion843 of the insertion member 840 and the distal end portion 814 of thetarget member 810. In other embodiments, for example, the electronicsignal 881 can be associated with a visual text message indicating thedistance between the distal end portion 843 of the insertion member 840and the distal end portion 814 of the target member 810 (e.g., a numericread-out indicating the distance in millimeters, inches, or any otherdesired units of measure).

As shown in FIG. 20 and described above, the distal end portion 813 ofthe target member 810 can be inserted into the body B through a firstincision (not shown in FIGS. 20 and 21) in the skin S. In this manner, adistal tip 816 of the target probe 814 can be positioned at a targetlocation T within the patient's body B (e.g., proximate a particularanatomical structure, at a desired depth or the like). Similarly, asshown in FIG. 20 and described above, the distal end portion 843 of theinsertion member 840 and/or the implant 802 can be inserted into thebody B, thereby placing the medical device 800 in a first configuration.When the medical device 800 is in the first configuration (FIG. 20), thedistal end portion 843 of the insertion member 840 and/or the implant802 is spaced apart from the distal tip 816 of the target probe 814 by adistance d₁. Moreover, when the medical device 800 is in the firstconfiguration, the electronic signal 881 produced by the electroniccircuit system 880 is proportional to the distance d₁.

As described above, the distal end portion 843 of the insertion member840 and/or the implant 802 can be moved within the body B by rotatingthe insertion member 840 relative to the target member 810 as shown bythe arrow SS in FIG. 21. In this manner, the medical device 800 can bemoved from the first configuration to the second configuration withinthe body B. When the medical device 800 is in the second configuration(FIG. 21), the distal end portion 843 of the insertion member 840 and/orthe implant 802 is spaced apart from the distal tip 816 of the targetprobe 814 by a distance d₂. Moreover, when the medical device 800 is inthe second configuration, the electronic signal 881′ produced by theelectronic circuit system 880 is proportional to the distance d₂. Inthis manner, the user can move the distal end portion 843 of theinsertion member 840 and/or the implant 802 within the body B inresponse to the electronic signals 881, 881′. Said another way, the usercan move the implant 802 from a region outside of the body to a regionwithin the body adjacent the target location T in response to theelectronic signals 881, 881′. Said yet another way, the user can use theelectronic signals 881, 881′ to guide the placement of the implant 802within the body B.

The electronic circuit systems shown and described above can includemany electronic components operatively coupled to perform the functionsdescribed herein For example, in some embodiments, the electroniccircuit system 880 can include a processor operatively coupled to amemory device (the components that can be included in the electroniccircuit system 880, such as the processor and the memory device, are notshown in FIGS. 20 and 21). The memory device can be configured to storeprocessor-readable code instructing the processor to perform thefunctions described herein. In some embodiments, the electronic circuitsystem 880 can include an input/output device configured to receiveelectronic inputs from an electrode, as described in more detail below.In some embodiments, the input/output device can receive one or moreinputs from any suitable source, such as, for example, the user's voice(e.g., through a microphone), a keyboard, a touch screen, a proximitysensor and/or the like. The input/output device can also configured toproduce and/or output the electronic signal 881, 881′ to various outputdevices, such as, for example, a visual output device, an audio outputdevice, and/or a haptic output device.

The processor that can be included within the electronic circuit system880 can be a commercially-available processing device dedicated toperforming one or more specific tasks. For example, in some embodiments,the processor can be a commercially-available microprocessor.Alternatively, the processor can be an application-specific integratedcircuit (ASIC) or a combination of ASICs, which are designed to performone or more specific functions. In yet other embodiments, the processorcan be an analog or digital circuit, or a combination of multiplecircuits.

The electronic signals 881, 881′ can be associated with any suitableelectrical characteristic and/or material property of the bodily tissuedisposed between the distal end portion 843 of the insertion member 840and/or the implant 802 and the distal tip 816 of the target probe 814.For example, in some embodiments, the electronic signals 881, 881′ canbe associated with an impedance between the distal tip 816 of the targetprobe 814 and the distal end portion 843 of the insertion member 840, aresistance between the distal tip 816 of the target probe 814 and thedistal end portion 843 of the insertion member 840, a capacitancebetween the distal tip 816 of the target probe 814 and the distal endportion 843 of the insertion member 840, and/or an inductance betweenthe distal tip 816 of the target probe 814 and the distal end portion843 of the insertion member 840. For example, FIG. 22 is a schematicillustration of a portion of a medical device 800′ configured to produceelectronic signals 881 _(Z1), 881 _(Z2) associated with an impedancebetween the distal tip 816 of the target probe 814 and the distal endportion 843 of the insertion member 840. Similar to the medical device800 described above with reference to FIGS. 21 and 22, the medicaldevice 800′ includes a target probe 814′, an insertion member 840′, andan electronic circuit system 880′. The target probe 814′ has a distaltip 816′ that includes an electrode 817 that is electronically coupledto and/or is included within the electronic circuit system 880, asindicated by the dashed lines in FIG. 22.

The insertion member 840′ includes a distal end portion 843′ that can beselectively coupled to an implant (not shown in FIG. 22), as describedabove. The distal end portion 843′ of the insertion member 840′ includesa first electrode 862 and a second electrode 863 spaced apart by adistance d_(cal). The first electrode 862 and the second electrode 863are electronically coupled to and/or are included within the electroniccircuit system 880, as indicated by the dashed lines in FIG. 22.

When the distal end portion 843′ of the insertion member 840′ isdisposed within the body (not shown in FIG. 22), the electronic circuitsystem 880′ is configured to measure the impedance Z1 between the firstelectrode 862 and the second electrode 863. Based on the impedance Z1and the known distance dcal, the electronic circuit system 880′ candetermine a characteristic impedance of the bodily tissue adjacent thedistal end portion 843′ of the insertion member 840′. The characteristicimpedance of the bodily tissue can be used to indicate the type oftissue within which the distal end portion 843′ of the insertion member840′ is disposed and/or to define a calibration coefficient fordetermining the distance d between the distal end portion 843′ of theinsertion member 840′ and the distal tip 816′ of the target probe 814′,as described below. Accordingly, the electronic circuit system 880 canproduce an electronic signal 881 _(Z1) associated with the impedance Z1.

When the distal end portion 843′ of the insertion member 840′ and thedistal tip 816′ of the target probe 814′ are disposed within the body,the electronic circuit system 880′ is configured to measure theimpedance Z2 between the first electrode 862 and/or the second electrode863 and the electrode 817 of the target probe 814′. The electroniccircuit system 880′ can then determine the distance d between the distalend portion 843′ of the insertion member 840′ and the distal tip 816′ ofthe target probe 814′ based on the impedance Z2 and the characteristicimpedance of the bodily tissue. For example, in some embodiments, thedistance d can be determined based on the following formula:d=d _(cal)*(Z2/Z1)Accordingly, the electronic circuit system 880 can produce an electronicsignal 881 _(Z2) associated with the impedance Z2. In other embodiments,the distance d can be determined based on any suitable formula oralgorithm. For example, in some embodiments, the distance d can bedetermined based on a nonlinear function of the impedance Z2. In otherembodiments, the distance d can be determined based on a predeterminedcalibration table that includes an array of values for the impedance Z2.

Although the medical device 800 is shown and described above asincluding an electronic circuit system 880 configured to produce anindication of the position of the distal end portion 843 of theinsertion member 840, in other embodiments, a medical device can beconfigured to produce a non-electronic indication of the position of aninsertion member and/or an implant within the body. For example, FIGS.23 and 24 are front views of a medical device 900 according to anembodiment of the invention. The medical device 900 includes a targetmember 910, an insertion member 940, and a position indicator 984. Thetarget member 910 has a proximal end portion 912 and a distal endportion 913. The distal end portion 913 includes a target probe 914configured to locate a target tissue T within the body B. For example,in some embodiments, the target probe 914 can be an electronicstimulating probe having an exposed electrode configured to stimulate amuscle, a nerve or the like and/or receive an electronic signal from amuscle, nerve or the like to locate the target tissue T.

The insertion member 940 has a proximal end portion 942 and a distal endportion 943. The distal end portion 943 of the insertion member 940 isconfigured to be selectively coupled to an implant 902, as describedabove. The proximal end portion 942 of the insertion member 940 isrotatably coupled to the proximal end portion 912 of the target member910 at a coupling joint 965. In this manner, the insertion member 940can rotate relative to the target member 910 about the coupling joint965. Accordingly, the medical device 900 is configured to insert theimplant 902 into the body B, in a similar manner as described above.

The position indicator 984 includes a gage portion 985 and an armportion 988. The gage portion 985 is coupled to the proximal end 912 ofthe target member 910 and includes a series of graduated markings 986.The arm portion 988 is coupled to the proximal end 942 of the insertionmember 940 and includes a pointer 989. The pointer 989 is configured tobe selectively disposed adjacent one of the graduated markings 986 inresponse to the position of the distal end portion 943 of the insertionmember 940 relative to the target probe 914. Said another way, the armportion 988 is movably coupled to the gage portion 985 such that thepointer 989 can be selectively disposed adjacent one of the graduatedmarkings 986 to indicate the position of the distal end portion 943 ofthe insertion member 940 relative to the target probe 914.

As shown in FIG. 23 and described above, the distal end portion 913 ofthe target member 910 can be inserted into the body B through a firstincision (not shown in FIGS. 23 and 24) in the skin S. In this manner, adistal tip 916 of the target probe 914 can be positioned at a targetlocation T within the patient's body B (e.g., proximate a particularanatomical structure, at a desired depth or the like). Similarly, asshown in FIG. 23 and described above, the distal end portion 943 of theinsertion member 940 and/or the implant 902 can be inserted into thebody B, thereby placing the medical device 900 in a first configuration.When the medical device 900 is in the first configuration (FIG. 23), thedistal end portion 943 of the insertion member 940 and/or the implant902 is spaced apart from the distal tip 916 of the target probe 914 by adistance d₁. Moreover, when the medical device 900 is in the firstconfiguration, the position indicator 984 produces an indicationassociated with the distance d₁. Similarly stated, when the medicaldevice 900 is in the first configuration, the pointer 989 is disposedadjacent one of the graduated markings 986 that is associated with thedistance d₁.

As described above, the distal end portion 943 of the insertion member940 and/or the implant 902 can be moved within the body B by rotatingthe insertion member 940 relative to the target member 910 as shown bythe arrow TT in FIG. 24. In this manner, the medical device 900 can bemoved from the first configuration to the second configuration withinthe body B. When the medical device 900 is in the second configuration(FIG. 24), the distal end portion 943 of the insertion member 940 and/orthe implant 902 is spaced apart from the distal tip 916 of the targetprobe 914 by a distance d₂. Moreover, when the medical device 900 is inthe second configuration, the position indicator 984 produces anindication associated with the distance d₂. Similarly stated, when themedical device 900 is in the first configuration, the pointer 989 isdisposed adjacent one of the graduated markings 986 that is associatedwith the distance d₂. In this manner, the user can move the distal endportion 943 of the insertion member 940 and/or the implant 902 withinthe body B in response to the indications produced by the positionindicator 984.

Although the medical device 200 is shown and described above asincluding one target probe 214, one insertion member 240, and oneimplant 202, in other embodiments, a medical device can include multipletarget probes, multiple insertion members and/or multiple implants. Forexample, in some embodiments a kit can include a medical deviceconfigured to insert an implant similar to the medical device 200 shownand described above. The kit can also include multiple target probes,each having different characteristics (e.g., length, diameter, electrodeconfiguration, tip geometry, etc.). In some embodiments, for example,the kit can include multiple insertion member, each having differentcharacteristics (e.g., size, radius of curvature, electrodeconfiguration, dilation configuration, etc.). Similarly, in someembodiments, the kit can include multiple implants of the types shownand described above.

The medical devices shown and described herein can be constructed fromany suitable material or combination of materials. For example, in someembodiments, an insertion member, such as insertion member 240, can be aconstructed from a rigid material, such as Nylon, a composite material,a metal alloy or the like. In other embodiments, an insertion member,such as insertion member 240, can be a constructed from a flexiblematerial. In this manner, the radius of curvature of the insertionmember can be changed based on the desired passageway within the bodyalong which the implant is to be inserted.

FIG. 25 is a flow chart of a method 1000 of inserting an implant into abody according to an embodiment of the invention. The method includesinserting a target probe along a first path within a body such that aportion of the target probe is disposed adjacent a target locationwithin the body, 1002. The target probe can be any target probe of thetypes shown and described above. In some embodiment, for example, targetprobe can be inserted by disposing a distal end portion of a targetportion of an implant delivery device against the body and moving thetarget probe within the first member of the insertion apparatus suchthat the portion of the target probe is disposed adjacent the targetlocation.

In some embodiments, the target probe can be an electromyogram (EMG)needle configured to be percutaneously inserted into the body toelectrically stimulate and/or receive an electronic signal from thetarget location within the body. Accordingly, in some embodiments, themethod optionally includes stimulating electronically a nerve and/or amuscle with the target probe after the inserting the target probe, 1004.

After the target probe is disposed adjacent the target location, anelectronic implant is inserted along a second path within the body suchthat a portion of the electronic implant is disposed adjacent the targetlocation within the body, 1006. The second path is different from thefirst path. For example, in some embodiments, a center line of thesecond path can be non-parallel to a center line of the first path.Moreover, the electronic implant is inserted when the target probe isdisposed adjacent the target location within the body.

In some embodiments, the electronic implant is inserted using an implantdelivery device of the type shown and described above. For example, insome embodiments, the electronic implant is inserted by moving aninsertion member of an implant delivery device relative to the targetprobe. As described above, the insertion member of the implant deliverydevice can be selectively coupled the electronic implant.

FIG. 26 is a flow chart of a method 1020 of inserting an implant into abody according to an embodiment of the invention. The method includesinserting a target probe of a first member of an implant delivery deviceinto a body via a first incision such that a portion of the target probeis disposed within the body adjacent a target location, 1022. The targetprobe can be any target probe of the types shown and described above. Insome embodiments, for example, a distal tip of the target probe can beconfigured to pierce, dilate and/or displace bodily tissue to define thefirst incision and/or a passageway within the body.

In some embodiments, the first member of the implant delivery device caninclude an anchor portion, of the types shown and described above.Accordingly, in some embodiments, the inserting the target probeincludes disposing the anchor portion of the implant delivery deviceagainst that body, and moving the target probe relative to the firstmember of the implant delivery device.

A second member of the implant delivery device is moved relative to thefirst member such that a distal end portion of the second member ismoved from a region outside of the body to the target location withinthe body via a second incision, 1024. The second incision is physicallydistinct from the first incision. Said another way, the first incisionand the second incision do not share a common boundary. The secondmember of the implant delivery device can be any movable member of thetypes shown and described above. Moreover, the distal end portion of thesecond member is selectively coupled to an electronic implant.Accordingly, in some embodiments, the method can optionally includedecoupling the electronic implant from the distal end portion of thesecond member, 1026. In this manner, the electronic implant can remainwithin the body after the implant delivery device is removed from thebody.

In some embodiments, the method optionally includes defining aninsertion passageway within the body before the moving, 1028. Theinsertion passageway can extend from the second incision to the targetlocation within the body and can be configured to receive the distal endportion of the second member of the implant delivery device. In someembodiments, for example, a portion of a center line of the insertionpassageway can be substantially normal to a center line of the targetprobe. In some embodiments, the insertion passageway can be defined bythe distal tip of the electronic implant and/or the distal end portionof the second member of the implant delivery device. In otherembodiments, the insertion passageway can be defined by a dilator thatis movably coupled to the first member of the implant delivery device.

FIG. 27 is a flow chart of a method 1040 of inserting an implant into abody according to an embodiment of the invention. The method includesengaging a target device with an outer surface of a body, 1040. Thetarget device, which can be similar to the target device 600 shown anddescribed above with reference to FIGS. 16-18, includes a first portionand a second portion. The first portion defines a lumen, and the secondportion defines a lumen. In some embodiments, for example, the engagingcan include coupling a portion of the target device to the outer surfaceof the body. For example, in some embodiments, the target device caninclude a contact surface having an adhesive configured to be coupled tothe skin of the body.

A distal end portion of a target probe is then inserted into the bodyvia the lumen of the first portion, 1044. In some embodiments, forexample, the target probe is inserted within the body such that thedistal end portion of the target probe is adjacent a target tissuewithin the body. In this manner, the insertion of the target probe isguided by the target member. In some embodiments, the method optionallyincludes stimulating electronically a nerve and/or a muscle with thetarget probe after the inserting the target probe, 1046.

The second portion of the target device is moved relative to the firstportion of the target device, 1048. In some embodiments, for example,the second portion of the target device is rotated relative to the firstportion of the target device. Said another way, in some embodiments, thesecond portion of the target device is moved relative to the firstportion of the target device such that an angle between the center lineof the lumen of the second portion and the center line of the lumen ofthe first portion is adjusted.

A distal end portion of an implant delivery member is then inserted intothe body via the lumen of the second portion, 1050. The implant deliverymember can be any implant delivery member (also referred to herein asimplant delivery tools) shown and described herein. The method canoptionally include decoupling the distal end portion of the implantdelivery member and the electronic implant such that the implant remainswithin the body.

FIG. 28 is a flow chart of a method 1060 of inserting an implant into abody according to an embodiment of the invention. The method includesinserting a distal end portion of a target probe into a body, 1062. Thetarget probe can be any target probe of the types shown and describedabove. For example, in some embodiments, the target probe can be anelectromyogram (EMG) needle configured to be percutaneously insertedinto the body to electrically stimulate and/or receive an electronicsignal from the target location within the body. Accordingly, in someembodiments, the method optionally includes stimulating electronically anerve and/or a muscle with the target probe after the inserting thetarget probe.

An implant is inserted into the body, 1064. The implant can be insertedusing any implant insertion tool of the types shown and describedherein. For example, in some embodiments, the implant can be insertedusing an implant delivery device movably coupled to the target probe. Insome embodiments, the implant can be inserted using an insertion toolhaving a distal end portion that is selectively coupled to the implant.

The implant can be any implant of the type shown and described herein.For example, in some embodiments, the implant can be an electricalimplant, such as, for example, a microstimulator, an elongate implant,an electronic lead, an electrode, a power supply, an amplifier and/or asensor. In other embodiments, the implant can be an implant that is notassociated with an electronic circuit system.

A distance between the distal end portion of the target probe and theimplant is measured after the distal end portion of the target probe andthe implant are within the body, 1066. In some embodiments, the distancecan be measured by measuring an impedance between the distal end portionof the target probe and the implant, a capacitance between the distalend portion of the target member and the implant, and/or an inductancebetween the distal end portion of the target member and the implant.Similarly, in some embodiments, the distance can be measured bymeasuring an impedance between the distal end portion of the targetprobe and the distal end portion of the implant delivery device, aresistance between the distal end portion of the target probe and thedistal end portion of the implant delivery device, a capacitance betweenthe distal end portion of the target member and the distal end portionof the implant delivery device, and/or an inductance between the distalend portion of the target member and the distal end portion of theimplant delivery device.

In some embodiments, the distance can be measured by measuring more thanone impedance value. For example, in some embodiments, the distance canbe measured by measuring a first impedance and a second impedance. Thefirst impedance is measured between a first electrode disposed at thedistal end portion of the insertion member and a second electrodedisposed at the distal end portion of the insertion member. The secondimpedance is measured between at least one of the first electrode or thesecond electrode and a third electrode disposed at the distal endportion of the target probe.

In some embodiments, the distance can be measured by an electroniccircuit system of the types shown and described above. Moreover, in someembodiments, the method optionally includes producing a textualindication associated with the distance between the distal end portionof the target probe and the implant, 1068. Similarly, in someembodiments, the method optionally includes producing a audibleindication associated with the distance between the distal end portionof the target probe and the implant, 1070.

The implant is moved within the body in response to the distancemeasured, 1072. In this manner, a user can move the implant from aregion outside of the body to a region within the body based on themeasured distance between the distal end portion of the target probe andthe implant.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above. Thus, the breadth and scope of theinvention should not be limited by any of the above-describedembodiments. While the invention has been particularly shown anddescribed with reference to specific embodiments thereof, it will beunderstood that various changes in form and details may be made.

For example, although many of the medical devices shown and describedabove include an insertion member that moves relative to a target memberwithin a plane, in other embodiments, a medical device can include aninsertion member configured to move relative to a target member in morethan one plane. Said another way, in some embodiments, a medical devicecan include an insertion member configured to move three-dimensionallyrelative to a target member. Moreover, such three-dimensional movementcan include rotational movement and/or translational movement.

Although the insertion member 140 is shown and described above as beingrotatably coupled to the target member 110, in other embodiments, aninsertion member can be removably coupled to a target member. Forexample, in some embodiments, a medical device can include an insertionmember 140 that is rotatably and removably coupled to a target member.In this manner, after the insertion member is inserted into the body, asdescribed above, the target member can be decoupled from the insertionmember and removed from the body while the insertion member is disposedwithin the body.

Although the medical device 200 is shown and described above asincluding a coupling member 264 having an adjustable length, in otherembodiments, a medical device can include any number of members havingan adjustable length. For example, in some embodiments, a medical devicecan include a target member having an adjustable length and/or aninsertion member having an adjustable length.

Although many of the medical devices shown and described above includean insertion member that is coupled to a target member either directlyor via a coupling member, in other embodiments, a medical device caninclude an insertion member that is operatively coupled to a targetmember via any suitable fashion. Said another way, in some embodiments,a medical device can include an insertion member and a target memberthat are devoid of a mechanical coupling, but that are operativelycoupled together. For example, in some embodiments, an insertion membercan be electronically coupled to a target member such that the insertionmember can move relative to the target member based on feedbackassociated with a distance between the insertion member and the targetmember.

Although the target members are shown and described above as beinginserted into the body such that a longitudinal axis of the targetmember is substantially normal to the skin, in other embodiments, atarget member can be inserted into the body such that a longitudinalaxis of the target member is angularly offset from the skin by anysuitable angle. For example, in some embodiments, the target member canbe inserted into the body such that the longitudinal axis of the targetmember angularly offset from the skin by approximately 45 degrees.Similarly, although the insertion members are shown and described aboveas being inserted into the body at an angle of between 30 and 60 degrees(see e.g., FIGS. 11-13, in other embodiments, an insertion member can beinserted into the body at any suitable angle. For example, in someembodiments, an insertion member can be inserted into the body at anangle less than 30 degrees. In yet other embodiments, an insertionmember can be inserted into the body at an angle greater than 60degrees.

Although the first lumen 622 and the second lumen 648 are shown ashaving a constant size (i.e., diameter), in other embodiments, the firstlumen 622 and/or the second lumen 648 can have a variable size. In thismanner, the movement of the target probe 614 within the first lumen 622and/or the movement of the insertion tool 640 within the second lumen648 can be limited. For example in some embodiments, the first lumen 622and/or the second lumen 648 can be tapered.

Although the implant insertion device 300 is shown as including a sheath352 and a dilator 354, in other embodiments, an implant insertion devicecan include any number of members movably coupled to a target portion.For example, in some embodiments, an implant insertion device caninclude a sheath, a dilator and an implant ejector.

Similarly, although the implant insertion device 300 is shown as usingthe dilator 354 to mechanically move the implant 302 within the lumen353 of the sheath 352, in other embodiments, an implant insertion devicecan employ any suitable mechanism to move the implant within the lumenof the sheath. For example, in some embodiments, an implant insertiondevice can include a pneumatic actuator to move an implant within asheath.

Although the medical devices are shown and described above as includingan implant delivery device and/or an electronic implant configured todisposed within a body, in some embodiments, a medical device caninclude a simulated implant delivery device and/or a simulatedelectronic implant. In such embodiments, for example, the simulatedimplant delivery device and/or the simulated electronic implant can beconfigured for use on a simulated target (e.g., a cadaver, a simulatedbody or the like). In some embodiments, for example, a simulated implantdelivery device can correspond to an actual implant delivery device ofthe types shown and described above and can be used, for example, totrain a user in the insertion of electronic implants into a body.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments, amedical device can include an target member, an insertion member, anadjustable-length coupling member, and an electronic circuit system. Theadjustable-length coupling member can be similar to coupling member 264shown and described above. The electronic circuit system can be similarto the electronic circuit system 880 shown and described above.

1. An apparatus, comprising: an implant delivery device configured todeliver an electronic implant into a body, the implant delivery deviceincluding a target portion and an insertion portion, the implantdelivery device having a first configuration and a second configuration,the target portion configured to be disposed within the body and conveyan electrical signal between a target location within the body and anelectrical device disposed outside of the body when the implant deliverydevice is in the first configuration, a distal end portion of theinsertion portion configured to be disposed outside of the body when theimplant delivery device is in the first configuration, the distal endportion of the insertion portion configured to be disposed within thebody at the target location when the implant delivery device is in thesecond configuration.
 2. The apparatus of claim 1, wherein the insertionportion is configured to be moved relative to the target portion.
 3. Theapparatus of claim 1, wherein: the target portion is configured to beinserted percutaneously from a first insertion location to the targetlocation within the body; and the distal end portion of the insertionportion is configured to define a passageway within the body, thepassageway extending from a second insertion location to the targetlocation, the second insertion location different than the firstinsertion location.
 4. The apparatus of claim 1, wherein: the distal endportion of the insertion portion is configured to be selectively coupledto the electronic implant; and the implant delivery device includes anactuator configured to selectively decouple the distal end portion ofthe implant from the electronic implant.
 5. The apparatus of claim 1,wherein the implant delivery device includes an anchoring portionconfigured to limit movement of the implant delivery device relative tothe body.
 6. An apparatus, comprising: an elongate member configured tobe selectively coupled to an electronic implant; and a target deviceincluding a first portion and a second portion, the first portiondefining a lumen configured to receive at least a portion of a targetprobe, the second portion defining a lumen configured to receive atleast a portion of the elongate member, the second portion of the targetdevice configured to move relative to the first portion of the targetdevice between a first position and a second position, a portion of acenter line of the lumen of the first portion and a portion of a centerline of the second portion defining a first angle when the secondportion of the target device is in the first position, the portion ofthe center line of the lumen of the first portion and the portion of thecenter line of the second portion defining a second angle when thesecond portion of the target device is in the second position, thesecond angle different than the first angle.
 7. The apparatus of claim6, wherein the target device includes an anchoring portion configured tobe coupled to an outer surface of a body, the anchoring portionconfigured to limit movement of the target device relative to the body.8. The apparatus of claim 6, further comprising: the target probeconfigured to inserted within the body via the lumen of the firstportion of the targeting device, the target probe configured toelectrically stimulate at least one of a nerve or a muscle when thetarget probe is within the body.